WASHINGTON – U.S. Sens. Chuck Grassley of Iowa and Elizabeth Warren of Massachusetts released a joint statement applauding the U.S. Food and Drug Administration on its action to make more affordable hearing aids available over the counter.
"We are pleased that the US Food and Drug Administration (FDA) will prioritize issuing rules for over-the-counter hearing aids in 2019. In 2017 we introduced the Over-the-Counter (OTC) Hearing Aid Act, a bipartisan bill to make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment and give consumers the option of an safe, high-quality device at lower cost. We applaud the FDA for working to make safe, more affordable hearing aids available to potentially millions of Americans."
Enacted in 2017, the law removes outdated regulations blocking consumer access to affordable hearing aids and requires that the FDA set regulations to ensure this new category of OTC hearing aids meets the same high standards for safety, consumer labeling and manufacturing protections as all medical devices. With its October 17, 2018, announcement that these rules are on the agency's Fall 2018 Unified Agenda, the FDA has confirmed it is making the new rules for OTC hearing aids a priority and will deliver proposed rules well in advance of the August 2020 statutory deadline.
Approximately 48 million Americans experience age-related hearing loss, including two-thirds of adults between the ages of 70 to 79. Yet only a small share of Americans with hearing loss – around 14 percent – use hearing aids, primarily due to their high cost. Hearing aids are not covered by Medicare or most private insurance plans, and out-of-pocket costs for a single hearing aid average $2,400 – far out of reach for many consumers.
The Over-the-Counter Hearing Aid Act of 2017 received endorsements from leading organizations representing seniors, consumers and hearing health professionals, including the AARP, the Gerontological Society of America, the Hearing Loss Association of America, Consumers Union, the National Committee to Preserve Social Security & Medicare, the Center for Medicare Advocacy, the American Federation of Teachers, the Consumer Technology Association, the Leadership Council of Aging Organizations, the Niskanen Institute, R St. Institute and the Academy of Doctors of Audiology.
The legislation was originally championed by U.S. Sens. Chuck Grassley of Iowa, Warren of Massachusetts, Maggie Hassan of New Hampshire, Johnny Isakson of Georgia, Susan Collins of Maine and Claire McCaskill of Missouri, along with Representatives Joe Kennedy III of Massachusetts, Marsha Blackburn of Tennessee, and a bipartisan group of thirteen other lawmakers in the House.
-30-